Study With Tocilizumab in Combination With Venetoclax and Azacitidine Chemotherapy in Patients With Acute Myeloid Leukemia

Starting soon · Phase 1

Conditions studied: Leukemia Acute Myeloid - AML

In brief

This is a phase 1, open label, interventional, single center, in patients with Acute Myeloid Leukemia (AML). This study will investigate dose escalation of tocilizumab in combination with venetoclax and azacitidine chemotherapy. The patient population will consist of adults men and women at least 18 years, who meet eligibility criteria. In this study propose combining tocilizumab with the standard treatment of azacitidine and venetoclax for patients with AML who are not eligible for intensive treatment.

Key facts

Study ID

NCT07392814

Run by

Nantes University Hospital

People needed

12

Starts

2026-03-10

Expected to finish

2030-07-10

Last updated by the study team

2026-02-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• First-line AML regardless of karyotype and molecular profile
• ECOG <= 3
• Patient eligible for chemotherapy combining azacitidine and venetoclax
• Informed consent
• Liver function tests: transaminases < 3x normal, bilirubin < 1.5x normal
• Creatinine clearance > 30 ml/min

You may not qualify if…

• LAM3
• Patients eligible for intensive "3+7" treatment
• Uncontrolled infection
• Active and/or treated infection with Hep B, C, or HIV
• No social security or other health insurance
• Pregnant women or patients who cannot use contraception due to fertility
• Breastfeeding women
• Minors
• Adults under guardianship, conservatorship, or legal protection
• Hypersensitivity to any of the active substances or excipients (see SPCs)
• Patients unable to understand spoken or written French

Where it is running

• CHU of Nantes — Nantes, France

Full record on ClinicalTrials.gov

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